IEC TR 60601-4-3
Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
|Publication Date:||1 April 2015|
|ICS Code (Medical equipment):||11.040|
This technical report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the third edition of IEC 60601-1.
This technical report is primarily intended to be used by:
- MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT;
- test laboratories and others responsible for assessment of
compliance with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:20
- those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC/TR 62296 were considered in preparing the third edition of IEC 60601-1. Similarly it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing a future revision of IEC 60601-1.